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The LiNA CystoVu HD is intended for use in visualization via LiNA displaying unit of adult male and female urethra and bladder cavity during diagnostic and therapeutic cystoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals.

The LiNA ScopeVu is intended for visualization from compatible LiNA endoscopes for female and male patients of all ages during diagnostic and therapeutic endoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals.

The LiNA CystoVu™ HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. Visualization will be achieved by LiNA Scope Vu™ full HD display and light source. The LiNA Cysto Vu™ HD is intended to be used with a reusable LiNA ScopeVu™ to visualize the urethra and the bladder. The LiNA CystoVu™ HD can be operated by the left or right hand. The optical module in the distal tip consists of a camera housing containing camera and LED light sources.

The provided text describes the LiNA CystoVu HD and LiNA ScopeVu, single-use flexible cystoscopes, and their substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study that proves the device meets those criteria with detailed device performance metrics, MRMC comparative effectiveness studies, standalone algorithm performance, or training set details as requested in your prompt.

The document focuses on demonstrating substantial equivalence to a predicate device (Ambu aScope 4 Cysto) through non-clinical performance testing.

Here's a breakdown of what can be extracted from the provided text based on your request, and what is missing:

1. Table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. The text states: "Non-clinical performance testing was conducted in order to demonstrate that the LiNA CystoVu HD and LiNA ScopeVu perform according to their requirements and specifications." It then lists the types of tests conducted:

2. Sample size used for the test set and the data provenance

This information is not provided. The non-clinical performance testing description does not specify sample sizes for individual tests or the provenance of any data used for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The testing described is primarily non-clinical and technical performance testing, not involving expert interpretation of medical images or diagnoses. Human factors testing included "Test participants representing the intended users," but their qualifications for establishing ground truth (in the diagnostic sense) are not relevant or mentioned.

4. Adjudication method for the test set

This information is not provided. Given the nature of the non-clinical performance tests conducted, an adjudication method as typically understood for clinical or image interpretation studies is not applicable or described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The document makes no mention of AI or an MRMC study. It describes a medical device (endoscope components) and its direct performance, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. There is no mention of an algorithm or standalone performance testing for AI components.

7. The type of ground truth used

For the technical and performance tests, the "ground truth" would be the engineering specifications, relevant ISO/IEC standards, and expected functional outcomes. For biocompatibility, it's the established safety profiles within ISO 10993. For sterilization, it's the validated SAL (Sterility Assurance Level).
The document explicitly states: "Clinical data was not used to support substantial equivalence of the subject device to the predicate device." This means there was no ground truth derived from pathology, expert consensus on clinical cases, or outcomes data in a clinical setting for substantial equivalence.

8. The sample size for the training set

This information is not applicable and not provided. There is no mention of an AI algorithm or a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided. There is no mention of an AI algorithm or a training set.

In summary: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence of a medical device (endoscope components) to a predicate device through non-clinical performance testing and technological comparison. It does not involve AI, clinical data for determining substantial equivalence, or detailed studies with the specific metrics the prompt is asking for related to AI performance, expert ground truth, or training sets.

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The SafeAir Combi is an electrosurgical generator containing an integrated surgical smoke evacuator. The unit is intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. When used with an electrosurgical pencil capable of surgical smoke evacuation, the console is also intended to remove and filtrate smoke generated during electrosurgical procedures.

SafeAir Combi (model: SFR-Combi-US) is an electrosurgical generator with the added functionality of smoke evacuation. This device is a non-sterile medical device, indicated to be used in operating theatres for use during general surgical procedures. SafeAir Combi uses 5 different output modes: 2 cut modes (Pure and Blend), 2 coagulation modes (Fulguration and Spray) and 1 mode for bipolar accessories. The device operates with a power range of 5-200 Watts for cut modes, 5-120 Watts for coagulation modes and 5-100 Watts for the bipolar mode. The device is intended to be used as a system together with monopolar or bipolar active accessories with a neutral electrode, however this submission is only intended to cover the electrosurgical generator and smoke evacuation feature and dedicated footswitch, without any active surgical accessories. Device is intended to be operated by healthcare professionals in hospitals and clinics where electrosurgical procedures are typically performed.

Here's a summary of the acceptance criteria and study information for the SafeAir combi (SFR-combi-US) device based on the provided text, where available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list a table of acceptance criteria with numerical targets. Instead, it refers to general performance testing and compliance with standards. However, it does provide a detailed comparison with predicate and reference devices, highlighting several operational characteristics and their similarity/difference. I'll construct a table based on the comparative performance characteristics mentioned and the implied "acceptance" of substantial equivalence.

2. Sample size used for the test set and the data provenance

The document does not specify the precise sample sizes for each performance test. It mentions "Comparative performance testing" and "Design Verification and Validation activities".

The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in terms of comparing the device against established predicate and reference device characteristics and regulatory standards. The testing itself would have been prospective (conducted specifically for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The testing described focuses on engineering and functional performance (e.g., electrical safety, thermal effects, smoke evacuation flow rates) rather than clinical diagnostic accuracy requiring ground truth established by medical experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable as the studies described are technical performance tests, not clinical studies requiring expert adjudication of outcomes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not conducted. The device is an electrosurgical generator with smoke evacuation, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is hardware (electrosurgical generator and smoke evacuator), not a standalone algorithm. Its performance is inherent in its operation and is evaluated through bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the test set predominantly relies on:

• Engineering specifications and regulatory standards: For electrical safety and EMC (IEC 60601 series).
• Physical measurements: For factors like power output, flow rates, filtration efficiency.
• Comparison to predicate/reference device characteristics: For functional aspects and parameter ranges.
• FDA Guidance: "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" for specific tests like thermal effects on tissue and ESU performance.

8. The sample size for the training set

This is not applicable. The SafeAir combi is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this device.

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LiNA OperaScope™ Needle is intended for hysteroscopic injection into the uterine wall as well as for cystoscopic injection in the urinary bladder wall.

LiNA OperaScope™ Needle is delivered as a sterile, single-use device designed to be used specifically with the LiNA OperaScope for hysteroscopic and cystoscopic injections. The device consists of a handle, a shaft and an injection needle, which is pointed at the distal end and has a luer-lock connection at the proximal end. Devices are packed in Tyvek pouches, with 6 units packed in a box.

The provided text does not describe an AI/ML device, therefore, the requested information focusing on acceptance criteria and studies for such devices, including details like test set provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set specifics, is not applicable.

The document discusses the substantial equivalence of a medical device, the LiNA OperaScope™ Needle, to a predicate device (Cook Injection Needles). The acceptance criteria and supporting studies are related to the physical performance, biocompatibility, and shelf-life of this non-AI medical instrument.

Here's the relevant information based on the provided text, adapted to the context of a physical medical device:

1. A table of acceptance criteria and the reported device performance

8. The sample size for the training set

Not applicable, as this is a non-AI/ML device. There is no concept of a "training set" for a physical medical instrument.

9. How the ground truth for the training set was established

Not applicable, as this is a non-AI/ML device.

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The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. The types of procedures where the LiNA OperaScope could offer visualization include:

• Assessment of abnormal bleeding, pelvic pain, amenorthea and abnormal findings from hysterosalpingogram
• Assessment of infertility and pregnancy wastage
• Confirmation of the presence of intrauterine foreign body
• Assist in locating submucosal fibroids and polyps targeted for removal
• Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine adhesions and septa.

The LiNA OperaScope can also be used to permit viewing of the adult female urinary bladder through minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

The LiNA OperaScope is a handheld, battery-operated portable hysteroscope which allows direct viewing of the cervical canal and uterine cavity via the on-board LCD display. If the user wants to capture images and/or record video sequences utilizing a USB stick, a Recording Module is available, which connects to the device via the HDMI cable. The LiNA OperaScope can also be connected to an external monitor via the HDMI cable. External monitors are not provided by LiNA Medical ApS and therefore, monitors are not the subject of this 510(k) submission.

The LiNA OperaScope is supplied as a sterile, single use device and the Recording Module is supplied as a non- sterile reusable unit. The LiNA OperaScope contains a miniature Complimentary Medical Oxide Semiconductor (CMOS) camera and a Light-Emitting Diode (LED) illumination at the tip, a channel for infusion of irrigating fluid and a channel for fluid outflow, a display), microelectronics, firmware and single use batteries for powering the device. The Recording Module contains microelectronics, software, controls for recording pictures and video sequences, USB port for storage of pic/video, HDMI port for connection of the LiNA OperaScope, HDMI port for connecting an external monitor and an input port for external 9V DC power supply.

The provided document is a 510(k) summary for the LiNA OperaScope, which is a medical device for visualizing the cervical canal, uterine cavity, and adult female urinary bladder. Notably, the document states "10. Clinical Performance Data: Not Applicable". This indicates that a clinical study, with human subjects, was not conducted to compare the device's performance against specific acceptance criteria.

Instead, substantial equivalence was demonstrated through non-clinical performance data, comparing the device to legally marketed predicate devices and against established standards. Therefore, I cannot provide a table of acceptance criteria with reported device performance from a clinical study, nor answer questions related to sample sizes for test/training sets, expert consensus, adjudication methods, or MRMC studies, as these types of studies were explicitly stated as "Not Applicable."

However, I can extract information regarding the non-clinical performance acceptance criteria and the methods used to prove the device met these criteria.

Summary of Acceptance Criteria and Device Performance (Non-Clinical):

Since no clinical performance data was deemed applicable, the device's performance was evaluated against non-clinical criteria. The acceptance criteria were met by passing various tests aligned with internal requirements, national standards, and international standards.

Table of Non-Clinical Acceptance Criteria and Reported Device Performance:

Regarding a "study that proves the device meets the acceptance criteria":

Based on the document, the "study" was a series of non-clinical performance tests that are detailed in section "9. Non-Clinical Performance Data". The device passed all these tests.

Based on the provided text, the following information cannot be extracted or is explicitly stated as "Not Applicable":

2. Sample sizes used for the test set and the data provenance:

• No human clinical test set was used for performance evaluation, as indicated by "Clinical Performance Data: Not Applicable". The "test set" in the context of non-clinical data would refer to the samples used for physical, electrical, and optical testing, but specific sample sizes for each non-clinical test are not provided. Data provenance would be from internal lab testing based on the referenced standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no human clinical test set was used requiring expert ground truth establishment for performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable as no human clinical test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a direct visualization tool, not an AI-assisted diagnostic tool, and no clinical study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a medical device, not an algorithm/AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical tests, the "ground truth" was established by the specifications and parameters defined within the relevant national and international standards (e.g., ISO, EN/IEC, ASTM) and the device's design inputs. For instance, for "Field of view," the ground truth is the specified range defined by ISO 8600-3.

8. The sample size for the training set:

• Not applicable, as this device does not involve a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set for a machine learning algorithm.

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SafeAir Smoke Evacuator compact is designed to remove and filter smoke generated during electrosurgical and laser procedures.

SafeAir Smoke Evacuator compact is a device with a vacuum pump that aspirates the surgical smoke produced during cauterization. The main purpose of smoke evacuation systems is to remove surgical smoke plume as close as possible to the surgical site. The component of the system ensuring that this is achieved is a diathermy pencil with integrated smoke evacuation function or a click-on tubing set connected to a surgical smoke evacuator. SafeAir Smoke Evacuator compact is designed for use in the hospital/clinic environment. It is built around a vacuum pump with a replaceable filter at the entry point. A specially designed pump control is centrally placed in the machine. The SafeAir Smoke Evacuator compact is designed with a pump with different activation functions; manual activation on the front panel, footswitch activation through diathermy pencil with smoke evacuation tubing. Synchronization is possible with most of the electrosurgical units.

The provided document is a 510(k) summary for the SafeAir Smoke Evacuator compact, a device designed to remove and filter smoke generated during electrosurgical and laser procedures. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance using AI or clinical studies. Therefore, much of the requested information regarding AI-specific studies, expert involvement, and ground truth establishment is not present in this regulatory submission.

However, I can extract information related to the device's functional performance and comparisons to the predicate device.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are not explicitly stated as separate acceptance criteria in the sense of predefined thresholds for clinical performance. Instead, the document demonstrates substantial equivalence by comparing technological characteristics and performance test results with the predicate device (Visiclear Smoke Evacuation System - K131402). The "acceptance" is implied by the similarity in performance to the predicate and compliance with relevant safety standards.

Here's a table based on the provided "Technological Characteristic Comparison Table" (Table 3), interpreted as performance demonstration against the predicate. The "Acceptance Criteria" column is derived from the predicate device's reported performance or general safety standards.

*All values obtained from simulated use testing.

2. Sample size used for the test set and the data provenance

The document mentions "simulated use testing" for flow rates. It does not specify a "test set" in terms of a dataset for AI evaluation, nor does it provide a sample size (number of tests or cases) for these simulated use tests. There is no information on data provenance (country of origin, retrospective/prospective) as this is a physical device performance test rather than an AI data study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The performance testing described is engineering/validation testing against physical parameters and standards, not clinical ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is described, as the testing involves objective measurements against engineering specifications and comparison with a predicate device, not subjective expert reviews.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was conducted or is relevant to this device. This is a smoke evacuator, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This refers to AI algorithm performance. No such study was conducted as the device is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is compliance with recognized electrical, mechanical, thermal, and chemical safety standards (e.g., IEC 60601-1, IEC 60601-1-2) and demonstrated functional performance (e.g., filtration efficiency, flow rates) that is "as safe, as effective and performs as well as or better than" the predicate device. This is primarily engineering and performance verification, not clinical ground truth.

8. The sample size for the training set

Not applicable. This device does not involve an AI algorithm with a training set.

9. How the ground truth for the training set was established

Not applicable. No AI training set.

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SafeAir Telescopic Smoke Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

SafeAir Telescopic Smoke Pencil is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

SafeAir Telescopic Smoke Pencil has got telescopic function which allows to extend the length of pencil by up to 120 mm. Extension is possible after twisting the green lock-ring.

The provided document is a 510(k) premarket notification for a medical device (SafeAir Telescopic Smoke Pencil). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial or algorithm validation.

Therefore, many of the requested pieces of information (acceptance criteria for a study, sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, standalone performance of an algorithm) are not applicable to this type of regulatory submission, as it is primarily about demonstrating that a new device is as safe and effective as an already cleared device through non-clinical testing and comparison of characteristics.

The document emphasizes substantial equivalence to a predicate device (Stryker Neptune E-SEP Smoke Evacuation Pencil, K160693) through:

• Identical intended use.
• Similar technological characteristics.
• Non-clinical performance data (bench testing) to show it meets safety and performance standards.

Here's an attempt to address the points based on the provided document, noting where information is not available or not applicable:

Acceptance Criteria and Study for the SafeAir Telescopic Smoke Pencil

The provided document is a 510(k) Premarket Notification, which seeks to demonstrate "substantial equivalence" of a new device to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical or algorithmic studies. Therefore, many of the requested details related to clinical trials, multi-reader studies, AI algorithm performance, and ground truth establishment (as typically seen in diagnostic device submissions) are not present or applicable in this context. The "acceptance criteria" here are primarily about meeting established safety and performance standards for electrosurgical devices and demonstrating equivalence to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implied by the standards and characteristics that the SafeAir Telescopic Smoke Pencil must meet to be considered substantially equivalent and safe/effective. The "reported device performance" is the manufacturer's assertion and testing results confirming the device meets these standards and is comparable to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of typical test sets for algorithmic or diagnostic performance. The "testing" refers to bench testing of the device itself (e.g., electrical safety, sterility), not a dataset of patients or images. The document does not specify the number of units tested for each non-clinical performance test.
• Data Provenance: The testing was conducted internally by the manufacturer (LiNA Medical ApS) based on internal requirements and international standards. (Page 8) The manufacturing facility is in Poland. (Page 5)

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. This is not a study requiring human expert interpretation of data (e.g., images for a diagnostic AI). The ground truth for device performance is established by a combination of engineering specifications, international standards (e.g., ISO, IEC, ASTM), and the expected performance of an electrosurgical device for its intended use.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" in the sense of data requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This is explicitly stated: "Based on the similarities in design, intended use and comparability in design verification results to the predicate device, human clinical testing was not required to establish substantial equivalence." (Page 8) This means no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable. This device is a manual medical instrument (an electrosurgical pencil), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for the device's acceptable performance is defined by adherence to recognized national and international consensus standards (e.g., ISO, IEC, AAMI/ANSI, ASTM for biocompatibility, electrical safety, sterilization, packaging, etc.), as well as its functional equivalence to a legally marketed predicate device. This is a demonstration of engineering validation and comparison, not clinical outcomes or expert consensus on clinical data.

8. The Sample Size for the Training Set

• Not applicable. There is no training set as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

• Not applicable.

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The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures.

The types of procedures where the OperaScope could offer visualization include:

· Assessment of abnormal bleeding, pelvic pain, amenorthea and abnormal findings from hysterosalpingogram;

• · Assessment of infertility and pregnancy wastage;
  · Confirmation of the presence of intrauterine foreign body;

· Assist in locating submucosal fibroids and polyps targeted for removal;

· Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine and septa.

The LiNA OperaScope is a handheld, battery-operated portable hysteroscope which allows direct viewing of the cervical canal and uterine cavity via the on-board LCD display. If the user wants to capture images and/or record video sequences utilizing a USB stick, a Recording Module is available, which connects to the device via the HDMI cable. The OperaScope can also be connected to an external monitor via the HDMI cable. External monitors are not provided by LiNA Medical ApS and therefore, monitors are not the subject of this 510(k) submission.

The OperaScope is supplied as a sterile, single use device and the Recording Module is supplied as a nonsterile reusable unit. The OperaScope contains a miniature Complimentary Medical Oxide Semi-conductor (CMOS) camera and a Light-Emitting Diode (LED) illumination at the tip, a channel for infusion of irrigating fluid and a channel for fluid outflow, a display unit (LCD display), microelectronics, firmware and single use batteries for powering the device. The Recording Module contains microelectronics, software, controls for recording pictures and video sequences, USB port for storage of pic/video, HDMI port for connection of the OperaScope, HDMI port for connecting an external monitor and an input port for external 9V DC power supply.

The provided text does not contain information about acceptance criteria for device performance, a study proving the device meets these criteria, or details regarding sample sizes, expert involvement, or adjudication methods for such a study.

The document is a 510(k) submission summary for the LiNA OperaScope, which focuses on demonstrating substantial equivalence to predicate devices based on:

• Indications for Use: The OperaScope's indications for use are compared to those of two predicate devices, affirming that its clinical use is not expanded.
• Technological Characteristics: A detailed comparison table (Table B) outlines features such as product code, regulation number, intended users, site of use, device features and components, optical image technology, image resolution, illumination source, inflow/outflow channel design, cannula tip design, image transmission, maximum insertion diameter, shaft/cannula length, LCD display size, energy source, sterilization methods, and tissue contact materials.
• Non-Clinical Performance Data: The submission lists a series of non-clinical performance tests conducted, including those for field of view, maximum width of insertion, biocompatibility, residual testing, electromagnetic compatibility, electrical safety, sterilization validation, mechanical testing, spatial resolution, a visualization and illumination study, in-flow and out-flow fluid delivery, functionality testing, shelf-life, battery lifetime, and software validation. These tests are stated to have been conducted in accordance with internal requirements, national, and international standards, and relevant FDA guidance.

The document asserts that the OperaScope "meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device," and that "The OperaScope passed all applicable testing." However, specific numerical acceptance criteria for these tests and their corresponding reported performance values are not provided in the text.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about the specific study proving the device meets these criteria, as this information is not present in the provided document.

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The SafeAir Smoke Pencil is designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The SafeAir Smoke Pencil is a sterile, single-use, integrated electrosurgical pencil and smoke evacuation handpiece. The device is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The integration of the electrosurgical pencil and smoke evacuation enables the operator to activate an electrosurgical current as well as capture smoke plume simultaneously. The SafeAir Smoke Pencil is available in two activation switch configurations, a rocker style and push-button style, which activate monopolar cut or coagulate functions. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to surgical smoke plume. Electrodes are available in either 70 mm blade or 70 mm coated blade configurations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SafeAir Smoke Pencil:

The document provided is a 510(k) summary for a medical device, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This type of submission typically focuses on demonstrating "substantial equivalence" rather than presenting a full clinical trial with acceptance criteria for new device performance. Therefore, the information provided isn't structured to detail specific acceptance criteria for diagnostic performance or a study proving those criteria in the way one might expect for a diagnostic AI device.

Instead, the document focuses on non-clinical performance testing to demonstrate the safety and effectiveness of the modified device in comparison to a predicate device. The "acceptance criteria" can be inferred from the types of tests performed and the statement that "results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the SafeAir Smoke Pencil and electrodes are sufficient for their intended use and support a determination of substantial equivalence."

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the document (a 510(k) summary for a modified electrosurgical pencil), explicit numerical acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity) are not provided, as this is not a diagnostic device. The "acceptance criteria" here relate to engineering performance, biocompatibility, and sterility.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of diagnostic AI (i.e., a dataset of cases used to evaluate an algorithm's classification performance). The testing described is non-clinical performance testing of the device itself.

• Sample Size: Not specified for individual non-clinical tests (e.g., how many pencils were tested for electrical safety, or how many materials for biocompatibility). The focus is on demonstrating compliance with standards and equivalence.
• Data Provenance: Not applicable in the context of clinical data provenance. The testing was performed on samples of the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. This device is not an AI diagnostic device that requires expert-established ground truth for a test set. The validation pertains to physical and electrical properties, and biological safety.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of clinical cases requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is designed for evaluating diagnostic devices, typically AI, and their impact on human reader performance. This device is an electrosurgical tool, not a diagnostic one.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not an AI algorithm. The device itself is a standalone medical instrument.

7. The Type of Ground Truth Used

The concept of "ground truth" as used in diagnostic AI is not applicable here. The "truth" for the non-clinical tests refers to compliance with established engineering standards (e.g., ISO 60601-1 for electrical safety, ISO 11135-1 for sterilization) and biocompatibility standards (ISO 10993-1).

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for an AI algorithm.

Summary of the Document's Focus:

This 510(k) submission is for a modification and line extension of an existing electrosurgical device (the SafeAir Smoke Pencil). The goal is to demonstrate "substantial equivalence" to a predicate device (K142538) by showing that the changes (electrode connector material, added accessories, pre-mounted components, and a new coated blade electrode) do not alter the intended use, indications for use, or fundamental scientific technology, and do not raise new questions of safety or effectiveness.

The "study that proves the device meets the acceptance criteria" refers to a battery of non-clinical performance tests covering:

• Biocompatibility (meeting ISO 10993-1)
• Sterilization validation (meeting ISO 11135-1 with a SAL of 10⁻⁶)
• Electrical safety (meeting ISO 60601-1 and 60601-2-2)
• Integrity and functionality after aging
• Thermal spread testing

The acceptance criteria for these tests are implicitly the successful demonstration of compliance with the relevant standards and the assurance that the device's performance is equivalent to, or better than, the predicate device. Specific numerical results for each test are not detailed in this summary document, but the conclusion states that the "results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness... are sufficient for their intended use and support a determination of substantial equivalence."

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The LiNA PowerBlade Plus™ HC is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated

The PowerBlade Plus HC is a sterile 5 mm single use instrument available in one 330mm length version with a 10mm jaw opening. The proposed device is a bipolar forceps device that grasps and coagulates utilizing electrical current. Transecting is done with a mechanical sharp blade. The LiNA PowerBlade Plus HC includes a rotation wheel on the handle that rotates the grasper jaws at the tip to improve positioning and ergonomics during the surgical procedure. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet. Two types of connectors are provided: the two pin connector is for use with most standard electrosurgical generators with a bipolar outlet, and a 3-pin connector that is attached to the cable of the LiNA PowerBlade Plus HC for use with ValleyLab™ generators with a LigaSure™ outlet. When the 3-pin connector is used, the control button on the hand piece can be used to activate the coagulation. When using the 2pin connector the coagulation function of the PowerBlade Plus HC is foot pedal controlled.

This document describes an FDA 510(k) premarket notification for a medical device and does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically associated with AI/ML-based medical devices or diagnostic tools.

Instead, this submission is for a traditional medical device (an electrosurgical cutting and coagulation device) and focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "acceptance criteria" here implicitly refer to the regulatory requirements for showing substantial equivalence, and the "study" is the non-clinical performance data and comparison to the predicate.

Given this, I will reframe the requested information in the context of this specific regulatory submission.

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not detail a "test set" in the sense of patient data or a specific clinical study with a defined sample size for statistical analysis of a diagnostic or predictive algorithm. Instead, the "testing" refers to non-clinical performance data and verification testing of the device's engineering and functionality.

• Sample Size for Non-Clinical Testing: Not explicitly stated (e.g., number of devices tested, number of cycles). This typically involves engineering benches and lab testing.
• Data Provenance: Not applicable in the context of patient data. The non-clinical testing would have been conducted by the manufacturer (LINA Medical ApS in Denmark) or contracted labs, adhering to recognized international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a submission for an electrosurgical instrument, not a diagnostic device requiring expert interpretation of medical images or patient data to establish ground truth. The "ground truth" for this device's performance would be objective measurements of coagulation, cutting, and mechanical function in a lab setting, against predefined specifications and recognized standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As there is no human interpretation of data requiring adjudication, this concept does not apply to the non-clinical verification testing mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI/ML diagnostic tool, and no MRMC study was conducted or required. The device is an electrosurgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm. It is a manually operated surgical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this type of device would be established through:

• Engineering specifications.
• Objective measurements obtained during mechanical and electrical testing (e.g., power output, temperature, tissue effects on surrogate materials, tip rotation, activation reliability).
• Compliance with recognized international standards (IEC60601-1, IEC60601-2-2).

8. The sample size for the training set

Not applicable. This device is not an AI/ML-based device and does not involve a "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this question is not relevant.

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The LiNA SafeAir Smoke Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The SafeAir Smoke Pencil is a sterile single use integrated electrosurgical pencil and smoke evacuation hand piece that is packaged with an electrode blade. The device is designed for general electrosurgical applications including cutting and coagulating and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The integration of the electrosurgical pencil and smoke evacuation enables the operator to activate an electrosurgical current as well as capture the smoke plume simultaneously. The proposed device is the same as the predicate SafeAir Smoke Pencil. The only modification is a change to the labeling to allow the use of the Stryker® Colorado MicroDissection Needle electrodes in addition to the electrode that is packaged with the hand piece.

The provided document describes a 510(k) premarket notification for the LINA SafeAir Smoke Pencil, specifically focusing on a modification to the existing device. This modification is a labeling change to allow the use of additional electrodes (Stryker® Colorado MicroDissection Needle electrodes) with the previously cleared device. Therefore, the device in question is an electrosurgical pencil, and the study described is to confirm compatibility with new electrodes, not to establish foundational performance for the pencil itself.

Here's the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the compatibility testing. It mentions "Testing was performed," but provides no numerical details. The data provenance is non-clinical performance data, likely from laboratory testing. No information on country of origin is provided for the test data, and it is a prospective test specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was non-clinical performance testing for device compatibility, not a study involving human assessment or interpretation for ground truth establishment.

4. Adjudication method for the test set

Not applicable. As this was non-clinical technical testing, there was no need for expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document describes a 510(k) submission for a medical device (an electrosurgical pencil), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This is a medical device, an electrosurgical pencil, not an algorithm.

7. The type of ground truth used

For the compatibility testing, the "ground truth" was objective technical measurements and functional verification against an established international standard (AAMI / ANSI / IEC 60601-2-2:2009, 201.15.4.1.102) and functional demonstration of current delivery.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device submission.

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